MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 43OD 28ID; PRSTHS,HIP,HMI,FMRL,MTL/PLYMER,CEMENTED OR UNCEMENTED

Catalog Number	71322043
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the returned bi-polar component was returned assembled with internal polyethylene components fully locked in place.Visually no damage to the component was observed.Visual examination on the head component did not find any damage.The head was place in the opening of the bi-polar component through which it would have had to pass in order to disassemble.This demonstrates the head diameter was large enough to be constrained within the bi-polar component as designed.No deviations of material or manufacturing process are indicated for these components.No conclusions as to the cause of this issue can be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 43OD 28ID
• Common Device Name: PRSTHS,HIP,HMI,FMRL,MTL/PLYMER,CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7509003
• Report Number: 1020279-2018-00911
• Device Sequence Number: 1528579
• Product Code: KWY
• UDI-Device Identifier: 03596010492425
• UDI-Public: 03596010492425
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 71322043
• Device Lot Number: 17MM01521
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 04/28/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 11/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR